Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4 May 2023, 4 November 2024, and 12 February 2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicant’s election of Group I (claims 33-38, 49-51, 56-57 and 59) in the reply filed on 6 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Application
3. The instant application is a national stage entry of PCT/US2021/058578 filed 9 November 2021. Claims 33-38, 49-51, 56-57, 59, and 65-72 are currently pending. Claims 1-32, 39-48, 52-55, 58, and 60-64 have been cancelled. Claims 65-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 March 2026. Claims 33-38, 49-51, 56-57 and 59 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(a) Scope of Enablement
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 33-38, 49-51, 56-57 and 59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for decreasing a viral load of a virus, does not reasonably provide enablement for preventing a viral particle of a virus from entering a host cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claimed invention is a method of preventing a viral particle of a virus from entering a host cell on a mucosal membrane of a subject by decreasing a viral load of the virus.
The state of the prior art: There are no methods described in the prior art or in the specification to completely prevent a viral particle from entering a host cell.
The relative skill of those in the art: The relative skill of those in the pharmaceutical development and medical treatment arts is high, requiring advanced education and training.
The predictability or unpredictability of the art/breadth of the claims: The instant claimed invention is highly unpredictable since one skilled in the art would recognize the breadth of the instant claims encompass prevention of a disease reliant upon host cell entry wherein each individual has a different immune system and health conditions that affect host cell entry. In addition, each viral particle has its own characteristics that affect host cell entry. Based on the disclosure of the prior art, one skilled in the art would view prevention of a viral particle from entering a host cell using the claimed composition as being highly unpredictable.
The amount of direction or guidance presented, and the presence or absence of working
examples: It has been established that “the amount of guidance or direction needed to enable the
invention is inversely related to the amount of knowledge in the state of the art as well as the
predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970). Example
12 shows the results of the polyinterferent composition on SARS CoV2 isolate hCoV19/South
Africa/KRISP-EC-K005321/2020 wherein 15 second exposure to the mouthwash reduced the
infection by 99.44% and 30 second exposure reduced by 99.99%. However, this does not reflect
100% infection. In addition, viruses are constantly changing to better infect a host. Positive results
for one strain of virus does not necessarily mean the same results would be achieved with another
strain. Data for one strain of virus is insufficient to encompass all strains.
The quantity of experimentation necessary: Given that the instant claims encompass complete prevention of virus particles from entering a host cell, one skilled in the art would undertake a novel and extensive research program to show that the instant claimed compositions reduce the risk of developing SARS-CoV2 from any strain for any host cell, i.e., adults, children, elderly, weakened immune systems, genetic disorders, etc. There are no teachings in the prior art to completely prevent such dysfunctions. Applicant fails to provide information sufficient to practice the claimed invention, absent undue experimentation. The burden of enabling the prevention of a disease would be much greater than that of enabling the treatment of such conditions. The specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing such conditions, or how a patient could be kept from every being susceptible to these conditions. There is no guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed active ingredients for preventing the above claimed conditions, thereby presenting an undue burden of unpredictable experimentation necessary to practice the claimed invention.
Genentech, 108 F.3d at 1366, states, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors as discussed above, particularly the unpredictability of the art and the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for a method of prevention of a viral particle from entering a host cell.
Claim Rejections – 35 U.S.C. 112(b)
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 35 and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Claim 35 recites “at least about 10 seconds”. It is unclear as to the lower limit of the claim. Since the phrase “about” is used, does the claim mean “at least 10 seconds”, “at least 9 seconds”, “at least 5 seconds”, etc.? Clarification is requested.
9. Claim 37 recites the limitation "the polyinterferent formulation" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is believed this should instead recite “polyinterferent composition” as cited in claim 33. It is noted that lines 3 and 5 further recite “the formulation” which would need to be amended accordingly.
Claim Rejections – 35 U.S.C. 112, 4th Paragraph
10. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
11. Claim 50 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 50 recites “the protocol further comprises administering an antihistamine composition and performing respiratory exercises.” This depends from claims 49 and 38, wherein claim 38 recites “administering an antihistamine composition and performing respiratory exercises.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections – 35 U.S.C. 103
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
13. Claim(s) 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (U.S. Patent Application Publication No. 2017/0165296) in view of Parikh et al. (WO97/40812).
Goodall et al. teach a method of treating a common cold by applying to the nasal passages an effective amount of a pharmaceutical preparation comprising povidone-iodine at a concentration of greater than 0.1 % w/v and less than 2.5%. See abstract. Goodall et al. teach that carrageenan has been shown to slightly reduce the duration of the cold. See paragraph [0021]. The composition additionally comprises a diluent, excipient or carrier including flavor, sweetener solvent, buffer, alcohol, etc. See paragraph [0123]. The composition may additionally comprise an antihistamine. See paragraph [0122]. Goodall et al. incorporates by reference Patent Application Publication No. 2010/0203166 by Rezakhany, which discloses methods for inhibiting respiratory infections by agitating or gargling an oral rinse or mouthwash in the throat and allowing vapors to penetrate the nasal passages, wherein iodine may be an ingredient in the oral rinse solution. See paragraph [0103].
Goodall et al. do not teach thymol, eucalyptol, menthol, methyl salicylate, or ethanol.
Parikh et al. teach an oral composition such as a gum or lozenge comprising an antimicrobial and anticalculus effective amount of zinc ions and an antimicrobial effective amount of essential oils including thymol, menthol, eucalyptol and methyl salicylate. Example 1 additionally comprises ethanol. A gelling or binding agent present in the composition may include iota-carrageenan. See page 6. Example 1 includes sorbitol and zinc chloride.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add thymol, menthol, eucalyptol, methyl salicylate, and zinc chloride to the formulation of Goodall et al. to provide additional antimicrobial and anticalculus effect. One would have been motivated, with a reasonable expectation of success to formulate a composition with additional therapeutic benefits.
14. Claim(s) 35-38 and 49-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (U.S. Patent Application Publication No. 2017/0165296) in view of Parikh et al. (WO97/40812) as applied to claims 33-34 above and further in view of Bidra et al. (Journal of Prosthodontics, 2020) and NeilMed.
Goodall et al. and Parikh et al. do not teach gargling at least twice a day for at least 10 seconds.
Bidra et al. teach the optimal contact time and concentration of viricidal activity of oral preparation of povidone-iodine (PVP-1) against SARS-COV-2 to mitigate the risk and transmission of the virus in dental practice. See abstract. PVP-oral antiseptics inactivated SARS-CoV-2 within 15 seconds of contact. See abstract.
NeilMed teach methods of rinsing nasal passages with NeilMed Sinus Rinse packets. Most users find that rinsing twice a day is beneficial, similar to brushing your teeth, but rinsing safely can occur up to six times a day. See page 4. Rinse helps alleviate nasal allergies, dryness, sinus pressure, nasal symptoms from flu and cold, nasal congestion and irritation. See page 5.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to gargle the formulation made obvious by Goodall et al. and Parikh et al. for at least 15 seconds to inactivate the virus. Since the prior art teaches gargling, the process should function in the same manner, meaning contacting deep throat mucosal membranes and decreasing viral load. It would have been obvious to irrigate the nasal cavities with saline solution prior to rinsing and gargling with the polyinterferent composition to alleviate nasal allergies, dryness, congestion and cold symptoms as taught by NeilMed. Since NeilMed teach rinsing two to six times a day, it would have been obvious to irrigate the nasal cavities, rinse, gargle and perform respiratory exercises at least twice a day to reduce symptoms and inactivate the virus to optimize the effect.
15. Claim(s) 56-57 and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bansal (BioRxiv, 2020) in view of Parikh et al. (WO97/40812) and Gronlund et al. (U.S. Patent Application Publication No. 2018/0168981).
Bansal teaches iota-carrageenan in concentrations as low as 6 µg/ml inhibits SARS-COV-2. See abstract. Iota-carrageenan nasal spray formulations are effective against rhinovirus and reducing symptoms of the common cold. See page 11. Xylitol also exhibits antiviral activity on SARS-CoV-2. See page 12. Table 1 combines iota-carrageenan with sodium chloride.
Bansal do not teach thymol, eucalyptol, menthol, methyl salicylate, or ethanol.
Parikh et al. teach an oral composition such as a gum or lozenge comprising an antimicrobial and anticalculus effective amount of zinc ions and an antimicrobial effective amount of essential oils including thymol, menthol, eucalyptol and methyl salicylate. Example 1 additionally comprises ethanol. A gelling or binding agent present in the composition may include iota-carrageenan. See page 6. Example 1 includes sorbitol and zinc chloride. Suitable buffers include citric acid, benzoic acid, and benzoate. Suitable preservatives include benzoic acid, sodium benzoate, butylated hydroxyanisole, tocopherols, etc. See page 8.
Gronlund et al. teach oral care compositions. See abstract. The composition may include iota-carrageenan and/or povidone iodine. See paragraphs [0077] and [0101]. The composition can be in the form of mouthwash or chewing gum. See paragraph [0091]. Preservatives include potassium sorbate and benzyl alcohol.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add thymol, menthol, eucalyptol, methyl salicylate, and zinc chloride to the formulation of Bansal to provide additional antimicrobial and anticalculus effect. One would have been motivated, with a reasonable expectation of success to formulate a composition with additional therapeutic benefits. It would have been obvious to formulate the composition as a chewing gum because both Gronlund et al. and Parikh et al. teach the known effective administration of iota-carrageenan and/or povidone iodine in chewing gum formulations. It would have been well within the purview of the skilled artisan to optimize the chewing gum design to maximize stability and delivery of active agents. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one preservative agent for another to yield predictable results. Since the prior art teaches both nasal formulations and chewing gum, it would have been obvious to formulate the combination of ingredients in both forms and combine administration to provide enhanced therapeutic efficacy.
Conclusion
16. No claims are allowed at this time.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
Prosecution Insights